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VELSIPITY Drug Patent Profile

When do Velsipity patents expire, and when can generic versions of Velsipity launch?

Velsipity is a drug marketed by Pfizer and is included in one NDA. There are seven patents protecting this drug.

This drug has ninety-eight patent family members in twenty-seven countries.

The generic ingredient in VELSIPITY is etrasimod arginine. Two suppliers are listed for this compound. Additional details are available on the etrasimod arginine profile page.

DrugPatentWatch^® Generic Entry Outlook for Velsipity

Velsipity will be eligible for patent challenges on October 12, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 12, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VELSIPITY

International Patents:	98
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Drug Prices:	Drug price information for VELSIPITY
What excipients (inactive ingredients) are in VELSIPITY?	VELSIPITY excipients list
DailyMed Link:	VELSIPITY at DailyMed

See drug prices for VELSIPITY

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VELSIPITY

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

216956

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for VELSIPITY

Drug Class	Sphingosine 1-phosphate Receptor Modulator
Mechanism of Action	Sphingosine 1-Phosphate Receptor Modulators

US Patents and Regulatory Information for VELSIPITY

VELSIPITY is protected by seven US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	VELSIPITY	etrasimod arginine	TABLET;ORAL	216956-001	Oct 12, 2023		RX	Yes	Yes
Pfizer	VELSIPITY	etrasimod arginine	TABLET;ORAL	216956-001	Oct 12, 2023		RX	Yes	Yes			Y	Y
Pfizer	VELSIPITY	etrasimod arginine	TABLET;ORAL	216956-001	Oct 12, 2023		RX	Yes	Yes
Pfizer	VELSIPITY	etrasimod arginine	TABLET;ORAL	216956-001	Oct 12, 2023		RX	Yes	Yes
Pfizer	VELSIPITY	etrasimod arginine	TABLET;ORAL	216956-001	Oct 12, 2023		RX	Yes	Yes

International Patents for VELSIPITY

See the table below for patents covering VELSIPITY around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2011529049
European Patent Office	3310760	SEL L-ARGININE CRISTALLIN D'ACIDE (R)-2-(7-(4-CYCLOPENTYL-3-(TRIFLUOROMÉTHYL)BENZYLOXY)-1,2,3,4-TÉTRAHYDROCYCLO-PENTA[B]INDOL-3-YL)ACÉTIQUE (COMPOSÉ 1) POUR UNE UTILISATION DANS DES TROUBLES ASSOCIÉS AU RÉCEPTEUR DE S1P1 (CRYSTALLINE L-ARGININE SALT OF (R)-2-(7-(4-CYCLOPENTYL-3-(TRIFLUOROMETHYL)BENZYLOXY)-1,2,3,4-TETRAHYDROCYCLO-PENTA[B]INDOL-3-YL)ACETIC ACID(COMPOUND1) FOR USE IN SIPI RECEPTOR-ASSOCIATED DISORDERS)
South Korea	102595163
China	116850181	治疗与S1P1受体有关的病症的方法 (Methods of treating conditions associated with s1p1 receptor)
Israel	285890

VELSIPITY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Velsipity

Introduction to Velsipity

Velsipity, also known as etrasimod, is a recent addition to the treatment options for ulcerative colitis (UC), a type of inflammatory bowel disease. Developed by Arena Pharmaceuticals and acquired by Pfizer through a $6.7 billion buyout in 2021, Velsipity has garnered significant attention in the pharmaceutical industry.

Market Approval and Competition

Velsipity has received approvals from key regulatory bodies, including the FDA in October 2023, the EMA in February 2024, and most recently, the UK approval in April 2024. These approvals mark significant milestones for Pfizer in the UC treatment market, which is highly competitive and dynamic[1][4].

The UC market is populated with various oral and injectable drugs, including Bristol Myers Squibb’s Zeposia, which shares a similar mechanism of action with Velsipity as an S1P receptor modulator. Other competitors include biologic drugs and JAK inhibitors like Xeljanz and Rinvoq[4].

Clinical Efficacy and Patient Benefits

Clinical trials, such as the ELEVATE 12 UC and ELEVATE 52 UC studies, have demonstrated Velsipity's efficacy in achieving clinical remission. The drug showed that 27% of patients achieved remission at 12 weeks and 32% at 52 weeks, significantly higher than the placebo group[1][4].

Market Positioning and Pricing

Velsipity is priced competitively, with a list price of $6,164 for a 30-day supply, or approximately $75,000 per year. This pricing is in line with other oral treatments like Xeljanz and Rinvoq, and lower than Zeposia, which was initially approved for multiple sclerosis and commands a higher price[4].

Financial Impact and Revenue Projections

Pfizer anticipates significant revenue from Velsipity, contributing to its overall financial growth strategy. The company expects to add $25 billion in revenue by 2030 from new products, including those acquired through biotech buyouts and licensings. This revenue will help offset declines from COVID-19 products and the loss of patent protection for older drugs[4].

In the context of Pfizer's broader financial performance, the company reported full-year 2023 revenues of $58.5 billion, a decline largely due to reduced revenues from Comirnaty and Paxlovid. However, excluding these contributions, Pfizer's revenues grew 7% operationally, driven by new product launches and in-line product growth[2].

Budget Impact and Cost Considerations

The budget impact of Velsipity on public drug plans is estimated to be positive, with potential savings of approximately $6 million over the next three years based on public list prices. However, the actual budget impact remains uncertain and will be influenced by the prices of other advanced UC therapies[3].

Competitive Landscape and Market Dynamics

The UC market is highly competitive, with multiple therapies receiving approvals in recent years. Velsipity faces direct competition from Zeposia, given their similar mechanisms of action and routes of administration. Other treatments, including biologic drugs and JAK inhibitors, also vie for market share[1][4].

Patient Needs and Unmet Gaps

Despite the availability of various treatments, there remains an unmet need for highly efficacious and convenient therapies for UC. Patients often cycle through several different treatments due to the unpredictable nature of the disease and may be apprehensive about using injectable biologic therapies[4].

Future Outlook and Pipeline Agents

The future of Velsipity in the UC market will depend on Pfizer's ability to assess market competition and patient needs. Pipeline agents in development for UC are expected to address the need for advanced therapies, potentially altering the market landscape further[1].

Financial Strategy and Cost Savings

Pfizer is on track to deliver at least $4 billion in annual net cost savings by the end of 2024 through its cost realignment program. This initiative, combined with the launch of new products and the realization of economies of scale, is expected to help the company return to pre-pandemic levels of gross margin by the end of 2024[2].

Risks and Challenges

While Velsipity presents a promising opportunity, there are risks associated with its market performance. These include the uncertainty of pipeline drugs passing clinical trials and receiving approval, as well as potential price reductions due to the Inflation Reduction Act[5].

Expert Insights

Filippos Maniatis, a healthcare analyst at GlobalData, noted that the UC market is highly competitive and dynamic, with ongoing unmet needs and a significant healthcare burden. He emphasized the need for Pfizer to assess market competition and patient needs to understand Velsipity’s future in this market[1].

Key Statistics and Figures

• Approval Dates: FDA approval in October 2023, EMA approval in February 2024, and UK approval in April 2024[1][4].
• Clinical Efficacy: 27% of patients achieved remission at 12 weeks and 32% at 52 weeks[4].
• Pricing: $6,164 for a 30-day supply, or approximately $75,000 per year[4].
• Revenue Projections: Expected to contribute to $25 billion in revenue by 2030[4].
• Budget Impact: Estimated savings of $6 million over three years for public drug plans[3].

Conclusion

Velsipity's entry into the UC market marks a significant development in the treatment of inflammatory bowel disease. With its competitive pricing, proven clinical efficacy, and strategic positioning, Velsipity is poised to make a substantial impact. However, the highly competitive nature of the UC market and ongoing unmet needs highlight the importance of continuous innovation and market assessment.

Key Takeaways

• Market Approval: Velsipity has received approvals from key regulatory bodies, including the FDA, EMA, and UK.
• Clinical Efficacy: Demonstrated significant remission rates in clinical trials.
• Competitive Landscape: Faces competition from Zeposia and other UC treatments.
• Financial Projections: Expected to contribute significantly to Pfizer's revenue growth.
• Patient Needs: Addresses unmet needs for convenient and efficacious UC therapies.
• Risks and Challenges: Includes uncertainties related to pipeline drugs and potential price reductions.

FAQs

Q: What is Velsipity used for? A: Velsipity (etrasimod) is used to treat ulcerative colitis (UC), a type of inflammatory bowel disease.

Q: How does Velsipity compare to other UC treatments? A: Velsipity is an S1P receptor modulator, similar to Zeposia, and is priced competitively with other oral treatments like Xeljanz and Rinvoq.

Q: What are the clinical efficacy rates of Velsipity? A: In clinical trials, Velsipity showed that 27% of patients achieved remission at 12 weeks and 32% at 52 weeks.

Q: How much does Velsipity cost? A: The list price for Velsipity is $6,164 for a 30-day supply, or approximately $75,000 per year.

Q: What are the potential financial impacts of Velsipity on Pfizer? A: Velsipity is expected to contribute to Pfizer's revenue growth, helping to offset declines from other products and supporting the company's financial strategy.

Cited Sources

1. Biopharma Reporter: "Pfizer's Velsipity UK approval to raise competition in ulcerative colitis market"
2. Pfizer Q4 2023 Earnings Release: "Pfizer Reports Full-Year 2023 Results and Reaffirms Full-Year 2024 Guidance"
3. NCBI Bookshelf: "Etrasimod (Velsipity)"
4. BioPharma Dive: "Pfizer wins FDA approval for its $7B colitis drug"
5. Krause Fund Research: "Current Students - Pfizer"